SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)

The SafeSept RF Transseptal Guidewire is a sterile, single-use guidewire (180 or 230 cm long, 0.032" or 0.035" diameter) designed to provide access to the left atrium via the right atrium during transseptal catheterization procedures. It uses radiofrequency (RF) energy (up to 10 watts) to cross the atrial septum and features echogenic markers and radiopaque coils for visualization.

The subject device incorporates RF energy delivery capability and uses a nitinol guidewire with platinum radiopaque coil, similar to the reference device. It differs from the predicate (VersaCross RF Wire) in materials and design features but shares the same fundamental approach of using RF energy to facilitate transseptal access. The guidewire has laser-etched markings and assumes a J-shape or retention curve when unsupported.

Electrical safety and EMC testing per IEC 60601-1-2 and IEC 60601-2-2. Biocompatibility testing per FDA 510(k) Memorandum #G95-1 and ISO 10993-1, including ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation), ISO 10993-11 (acute toxicity/pyrogenicity), ISO 10993-3 (genotoxicity), and ISO 10993-4 (hemocompatibility). Also performed visual/dimensional inspection, sterile testing, simulated use testing, package testing, and transit testing.

The SafeSept RF Transseptal Guidewire is substantially equivalent to the VersaCross RF Wire predicate because both are guidewire-based transseptal access systems using RF energy to cross the interatrial septum, operate within the same procedural workflow, and allow advancement of transseptal introducers. Although materials and design details differ, these differences do not alter the fundamental intended use or mechanism of action and do not raise new questions of safety or effectiveness.